The evolution of DHE for at-home use

TITLE: How has DHE evolved to change the at-home treatment landscape?

Sheena Aurora, MD: Many of us have heard or have used dihydroergotamine, DHE. In fact, this drug has been around for more than 70 years, and it has proven efficacy.

We use it to break a cycle of migraine, or we’ll use it when other treatments have failed, because unlike other oral medications, dihydroergotamine has had a profile that hits multiple receptors. It’s a molecule that is versatile; it has been used in the IV, in subcutaneous, as well as intramuscular formulations.

In particular, when patients need freedom of pain without a treatment window, IV DHE provides that relief.

The trouble with DHE at home has been an inconsistent absorption, particularly with traditional nasal sprays.

In September of 2021, Trudhesa got approved. Trudhesa uses the same liquid formulation of dihydroergotamine but uses a proprietary delivery system called POD®, or Precision Olfactory Delivery system, that targets the upper nasal space. The “so what” from this delivery system is that you don’t get wastage of drug either into the oral cavity or as a drip in front of the nose.

The studies that were done to get Trudhesa through regulatory approval were predominantly safety studies. In these studies, the primary endpoints were to look at nasal safety. Patients who had cardiovascular risk factors were also included and we found no new treatment-emergent adverse events as it relates to cardiovascular disease, such as changes in blood pressure, pulse, or EKG changes.

The most common adverse events that were reported in the STOP 301 study for Trudhesa were local, which included nasopharyngitis at 21%, and rhinitis at 19%.

Although these were not prespecified, we also did some exploratory efficacy endpoints from the Trudhesa safety study. We have been able to demonstrate that the location of the delivery can make a difference. 38% of patients reported freedom from pain at two hours from their first attack that they’re treated with Trudhesa. With regards to most bothersome symptom, that rate was 52%. Further, the relief was felt as early as 15 minutes, and 66% of patients reported pain relief at two hours.

So when you’re considering your armamentarium, there are patients who can certainly use a more broad-spectrum approach. We also have to remember that there is a dysfunction in the gut-brain interaction, particularly for patients with migraine, and a non-oral route that is consistently delivered becomes very, very important.